FDA again rejects Alexza's Adasuve, citing manufacturing deficiencies

California, USA-based Alexza Pharmaceuticals (Nasdaq: ALXA) revealed last week that it has received another Complete Response Letter from the Food and Drug Administration regarding its New Drug Application for the antipsychotic drug candidate Adasuve (Staccato loxapine) inhalation powder, citing certain deficiencies at its Mountain View manufacturing facility.

Loxapine already is approved in a capsule form for long-term treatment of schizophrenia, but Alexza is seeking approval for an inhaled form that would be administered for acute agitation associated with schizophrenia or bipolar I disorder in adults. The news saw the company’s stock fall to $0.38 Friday morning, down from a close of $0.61 the day earlier.

The latest CRL was issued by FDA's Center for Drug Evaluation and Research indicating that the NDA review cycle is complete and the application is not ready for approval in its present form. In a previous CRL, the FDA stated that its primary clinical safety concern was related to data from three Phase I pulmonary safety studies with the drug (The Pharma Letter October 12, 2010).